A two-arm multicenter phase II trial of one cycle chemoselection split-dose docetaxel,cisplatin and 5-fluorouracil (TPF) induction chemotherapy before two cycles of split TPF followed by curative surgery combined with postoperative radiotherapy in patients with locally advanced oral and oropharyngeal squamous cell cancer (TISOC-1) |
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| Affiliation: | 1. Department of Otorhinolaryngology;;2. Clinic for Internal Medicine II – Department of Hematology and Internal Oncology, Jena University Hospital, Jena;;3. Department of Otorhinolaryngology/Plastic Surgery, University Hospital Leipzig, Leipzig;;4. Department of Otorhinolaryngology, Head and Neck Surgery, Ulm University Medical Center, Ulm;;5. Departments of Hematology, Oncology & Palliative Care; Hematology, Oncology & Palliative Care;6. Department of Otorhinolaryngology, Klinikum Ernst von Bergmann, Potsdam;;7. Department of Hematology, Oncology and Palliative Care;;8. Department of Radiation Oncology, University Medical Center, Rostock;;9. Departments of Hematology and Oncology; Hematology and Oncology;10. Department of Otorhinolaryngology, Head and Neck Surgery, Academic Teaching Hospital Bielefeld, Bielefeld;;11. Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Giessen and Marburg, Giessen, Germany |
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| Abstract: | BackgroundInduction chemotherapy (ICT) with docetaxel, cisplatin and fluorouracil (TPF) followed by radiotherapy is an effective treatment option for locally advanced head and neck cancer. This phase II study investigated the effectivity of a split-dose TPF ICT before surgery for locally advanced resectable (stage III/IVA) oral and oropharyngeal cancer.Patients and methodsPatients received TPF split on two dosages on days 1 and 8 per cycle (30 mg/m2 docetaxel, 40 mg/m2 cisplatin, 2000 mg/m2 fluorouracil per week). Responders (reduction tumor volume ≥30% after first cycle) received three 3-week cycles and non-responders only one cycle before surgery and postoperative radio(chemo)therapy (RCT). The primary endpoint was progression-free survival rate after 24 months. Secondary endpoints were amongst others overall survival, histopathological response to ICT, toxicity, quality of life and swallowing function.ResultsFifty-four patients (91% stage IVA, 87% male, 72% oropharyngeal cancer, 70% responders) were eligible for a per-protocol analysis. The progression-free survival rate after 24 months was 88.5% for responders and 60.6% for non-responders (P = 0.005). The overall survival rate after 24 months was 97.3% for responders and 73.7% for non-responders (P = 0.032). The rate of histopathological complete remission of the primary tumor was higher in responders (P = 0.015). High-risk classification for postoperative RCT was lower in responders (P < 0.0001). The most common grade 3+ adverse event was neutropenia in 26% of patients during ICT and mucositis in 13% during postoperative RCT. During treatment and follow-up quality of life and swallowing function was not different between responders and non-responders.ConclusionPatients with oral and oropharyngeal cancer responding to split-dose TPF before surgery and postoperative RCT show good oncological results. The tri-modal treatment regime was well tolerated. ICT using tumor response as criterion for duration of ICT before surgery of oral and oropharyngeal cancer merits additional investigation in a phase III study.Clinical trial numberNCT01108042. |
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